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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 16, 2019 to June 5, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was considered not to be suitable for the test substance.

Test material

Constituent 1
Reference substance name:
Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts
Cas Number:
2210238-42-7
IUPAC Name:
Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts
Test material form:
liquid
Remarks:
Colorless Clear Liquid
Details on test material:
Expiration date: August 2021

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Guinea pig, Hartley (Slc:Hartley, closed colony), SPF
- Age at study initiation: 5 Weeks old
- Weight at study initiation: 300–355 g
- Housing: The animals were housed 5 or 6 per cage during the quarantine and acclimatization period, and 5 per cage during the experimental period.
- Diet: Pellet diet LRC4 (Lot No. 190207, 190305; Oriental Yeast Co., Ltd.) was offered ad libitum.
- Water: Municipal tap water filtered through a 5-µm cartridge filter and sterilized with an ultraviolet sterilizer was offered ad libitum through an automatic water-supply system.
- Acclimation period: For 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Actual values, 21.9°C-25.2°C (Set value, 23°C; acceptable range, 20°C-26°C)
- Relative humidity: Actual values, 43.2%-69.7% (Set value, 50%; acceptable range, 30%-70%)
- Ventilation frequency: 12 Times /hour
- Light period: 12 Hours/day (on at 6:00 AM, off at 6:00 PM)

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Remarks:
For Topical induction: Water for injection
Concentration / amount:
For Intradermal induction: 0.1 w/w%
For Topical induction: 1 w/w%
Day(s)/duration:
For Intradermal induction: 7 days
For Topical induction: 48hrs
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Water for injection
Concentration / amount:
0.3, 0.1, and 0.05 w/w%
0.1 mL
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 animals in the test-substance sensitization group
5 animals in the control group
Details on study design:
RANGE FINDING TESTS: In a non-GLP preliminary study, skin reaction to the intraderrnal injection of the test substance at 0.5, 0.3, 0.1, 0.05, 0.03 and 0.01 w/w% was as follows: Score-4 necrosis with Score-2 edema at 0.5 and 0.3w/w%; Score-1 erytherna at 0.1 and 0.05 w/w%; and no reaction at 0.03 w/w% and lower. The results for occlusive application at 5, 3, 1, 0.5, 0.3 and 0.1 w/w% were as follows: Score-4 eschar with Score-2 edema at 5 and 3 w/w%; Score-2 erythema with Score-1 edema at 1 w/w%; Score-1 erythema at 0.5 w/w%; and no reaction at 0.3 w/w% and lower.
Based on these results, 0.1 and 1 w/w% was selected for intradermal and topical induction, respectively. For challenge, 3 concentrations of 0.3, 0.1, and 0.05 w/w% were selected.

MAIN STUDY
1. INDUCTION EXPOSURE
For intradermal induction of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the shaved skin of the dorsal neck of the guinea pigs:
A, An emulsion of equal volumes (v/v) of FCA and physiological saline;
B, Test-substance solution at 0.1 w/w% (vehicle: physiological saline);
C, An emulsion of equal volumes (v/v) of 0.2-w/w¾ test-substance solution (vehicle: physiological saline) and FCA.
For contact sensitization, 0.2 mL of the test-substance solution at 1 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours.
The control animals were treated in the same manner with the vehicles for each sensitization.

2. CHALLENGE EXPOSURE
For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24 hour occlusive application was made on the right and left lateral region.
Observation of skin reaction was performed 24 and 48 hours after patch removal.
Positive control substance(s):
not required

Results and discussion

Positive control results:
see attachements

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.3, 0.1, and 0.05 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Remarks on result:
other: see attachments
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.3, 0.1, and 0.05 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Remarks on result:
other: see attachments
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3, 0.1, and 0.05 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Remarks on result:
other: see attachments
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3, 0.1, and 0.05 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Remarks on result:
other: see attachments
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3, 0.1, and 0.05 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Remarks on result:
other: see attachments
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3, 0.1, and 0.05 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Remarks on result:
other: see attachments

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the above results, the test substance is considered to have no skin-sensitization potential under the conditions of this study.
Executive summary:

The skin-sensitization potential of C16K was investigated by the guinea-pig maximization-test method.


A total of 15 animals were used as follows: 10 animals in the test-substance sensitization group and 5 animals in the control group.


For intradermal induction of the test-substance sensitization group, 0.1 mL each of the following was intradermally injected into 2 sites of the cervical region: Emulsion of equal volumes of Freund's complete adjuvant (FCA) and physiological saline, Test-substance solution at 0.1 w/w% (vehicle: physiological saline), and Emulsion of equal volumes of the test-substance solution at 0.2 w/w% (vehicle: physiological saline) and FCA. For topical induction of the test-substance sensitization group, a 2x4-cm piece of lint, impregnated with 0.2 mL of the 1-w/w% test-substance solution (vehicle: water for injection), was occlusively applied onto the same site as the intradermal injection, and kept for 48 hours. The control animals were treated in the same manner with the vehicles for each induction. For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, and 0.05 w/w% was impregnated into a 1.5x1.5-cm piece of lint on the day 21 of the induction, and 24-hour occlusive application was made on the lateral region.


Assessment of skin reaction was performed 24 and 48 hours after patch removal for challenge.


As results, no skin reaction was induced by any formulation for challenge in the test-substance sensitization group or control group.


No animals showed any abnormalities in the general condition, and body weights increased in the experimental period.


 


Based on the above results, the test substance is considered to have no skin-sensitization potential under the conditions of this study.